View older revisions Content changed at 2024-09-21, 1403/06/31

Protocol summary

Study aim
Determining the Effect of Virtual Psychological Hot Wash on Pre-hospital Emergency Staff Anxiety and Stress
Design
Clinical trial with control group, with parallel groups, without blinding, randomized, phase 3 on pre-hospital emergency staff. Excel software rand function was used for randomization.
Settings and conduct
The research site will be the Accident Management Center of Qom University of Medical Sciences. Before the intervention, participants' stress and anxiety scores will be measured in both intervention and control groups. Then a virtual psychological hot wash program will be performed for the intervention group for one month. No intervention will be performed for the control group. 30 and 72 days after the intervention, the stress and anxiety scores in both intervention and control groups will be measured, and the obtained data will be compared.
Participants/Inclusion and exclusion criteria
Pre-hospital emergency staff with one year of work experience will participate in this study. The study will not include pre-hospital emergency staff with a history of untreated mental illness.
Intervention groups
Intervention group: Pre-hospital emergency staff will participate in the virtual psychological hot wash program after the end of the night shift and with the presence of a psychologist in the pre-hospital emergency management room through the cyberspace of Adobe Connect software. Control group: Pre-hospital emergency services will not receive any intervention.
Main outcome variables
Stress, Anxiety

General information

Reason for update
Unexpected delay in sampling time.
Acronym
IRCT registration information
IRCT registration number: IRCT20121107011399N7
Registration date: 2022-05-09, 1401/02/19
Registration timing: prospective

Last update: 2024-09-21, 1403/06/31
Update count: 1
Registration date
2022-05-09, 1401/02/19
Registrant information
Name
Abbasali Ebrahimian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3107 1082
Email address
ebrahimian.aa@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Virtual Psychological Hot Wash on Pre-hospital Emergency Staff Anxiety and Stress
Public title
The Effect of Psychological Hot Wash on Anxiety and Stress
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Degree or bachelor's degree in medical emergencies Work experience for at least one recent year The employee does not suffer from previously known mental and physical disorders.
Exclusion criteria:
Unwillingness to participate in research
Age
From 22 years old to 52 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done in two steps. The first step will be to select the samples from the research community using a table of random numbers. Since the number of pre-hospital technicians working in Qom Accident Management Center is known (253 people), each research community member will be given a code. Then the samples (60 people) will be randomly selected using the Rand company function. In the next step, 60 selected codes are divided into two groups of intervention and control using the lottery method.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Street address
Room #243, 1st floor, School of Paramedic, Qom University of Medical Sciences, Al-Qadir Highway., Qom-Iran.
City
Qom
Province
Ghoum
Postal code
3736175513
Approval date
2022-01-02, 1400/10/12
Ethics committee reference number
IR.MUQ.REC.1400.212

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition

2

Description of health condition studied
Stress
ICD-10 code
F43
ICD-10 code description
Reaction to severe stress, and adjustment disorders

Primary outcomes

1

Description
Anxiety score in the Spielberger Anxiety Questionnaire
Timepoint
Measurement of anxiety at the beginning of the study (before the intervention) and 30 and 72 days after the implementation of the virtual hot wash program
Method of measurement
The Spielberger Anxiety Questionnaire

2

Description
Stress score in Cohen's Perceived Stress Questionnaire
Timepoint
Measurement of stress at the beginning of the study (before the intervention) and 30 and 72 days after the implementation of the virtual hot wash program
Method of measurement
The Cohen's Perceived Stress Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Virtual Psychological Hot Wash sessions will be held immediately after the night shift and with the presence of a psychologist (a fixed person in all stages) in the pre-hospital emergency management room through the virtual space of Adobe Connect software for one month. The steps of psychological hot washing will be done as follows: first, what happened will be discussed (reality stage); In the next stage, how the person thinks about problems and his decisions about the processes involved and personal meanings (thinking stage); Then the domain associated with the emotional response (reaction phase); And other reactions experienced (symptom stage) will be measured. In the next step, training on coping strategies will be done. Finally, in the re-entry phase, this process is reviewed and ends with a discussion of the issues and a return to daily life.
Category
Treatment - Other

2

Description
Control group: Pre-hospital emergency staff in the control group will not receive any intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Qom Medical Emergency and Accident Management Center
Full name of responsible person
Hamid-Reza Bagheri
Street address
Medical Emergency and Accident Management Center of Qom Province, 15 Khordad Blvd, Qom.
City
Qom
Province
Ghoum
Postal code
3714854719
Phone
+98 25 3777 4422
Email
ems@muq.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mahdi Mesri
Street address
Qom University of Medical Sciences and Health Services, Shahid Lavasani St. (Coastal)
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 1771 3550
Email
Pres@muq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Abbasali Ebrahimian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Room #243, 1st floor, School of Paramedic, Qom University of Medical Sciences, Al-Qadir Highway., Qom-Iran.
City
Qom
Province
Ghoum
Postal code
3736175513
Phone
+98 25 3197 1082
Email
aebrahimian@muq.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Abbasali Ebrahimian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health in Emergency and Disaster
Street address
Room #243, 1st floor, School of Paramedic, Qom University of Medical Sciences, Al-Qadir Highway., Qom-Iran.
City
Qom
Province
Ghoum
Postal code
3736175513
Phone
+98 25 3197 1082
Email
aebrahimian@muq.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Abbasali Ebrahimian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health in Emergency and Disaster
Street address
Room #243, 1st floor, School of Paramedic, Qom University of Medical Sciences, Al-Qadir Highway., Qom-Iran.
City
Qom
Province
Ghoum
Postal code
3736175513
Phone
+98 25 3197 1082
Email
aebrahimian@muq.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Participants' personal data will be shared after their names are removed.
When the data will become available and for how long
Data access will start from the beginning of 2025 for six months.
To whom data/document is available
The reviewers of the research project and the reviewers of the scientific article obtained from this research will be allowed to access the data.
Under which criteria data/document could be used
The data will be sent to the reviewers.
From where data/document is obtainable
To receive data, write to aebrahimian@muq.ac.ir.
What processes are involved for a request to access data/document
The person who needs to review the data sends an email to aebrahimian@muq.ac.ir, in which he introduces himself and specifies the reason for the need for the data. If the applicant is one of the reviewers, the data will be sent to him/ her via email.
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